Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/3/2019 |
| Start Date: | August 2013 |
| End Date: | July 2020 |
| Contact: | Guillermo Tearney, MD., PhD |
| Email: | gtearney@partners.org |
| Phone: | 617-724-2979 |
Pilot Study for Imaging of the Duodenum Using an OFDI Capsule
The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule
to image the duodenum.
A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake
and unsedated and ask for their feedback. Images will be taken using the OFDI system while
the capsule travels from the esophagus into the stomach and into the duodenum.
to image the duodenum.
A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake
and unsedated and ask for their feedback. Images will be taken using the OFDI system while
the capsule travels from the esophagus into the stomach and into the duodenum.
Subjects including healthy volunteers as well as patients with Celiac disease will be
recruited and asked to swallow the OFDI capsule while being awake and unsedated. The capsule
is attached to a tether which allows the operator to control as well as navigate the capsule
as it progresses down the esophagus, through the stomach and into the duodenum using natural
propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross sectional images of the duodenum are
acquired. Images are analyzed at a later stage.
recruited and asked to swallow the OFDI capsule while being awake and unsedated. The capsule
is attached to a tether which allows the operator to control as well as navigate the capsule
as it progresses down the esophagus, through the stomach and into the duodenum using natural
propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross sectional images of the duodenum are
acquired. Images are analyzed at a later stage.
Inclusion Criteria:
- Subject must be over 18 years for healthy volunteers
- Subjects must be over 16 years for patients with Celiac disease
- Subject must be able to give informed consent
Exclusion Criteria:
- Subjects with an inability to swallow pills or capsules.
- Subjects with esophageal or intestinal fistulas.
- Subjects with known esophageal or intestinal strictures resulting in a luminal
diameter smaller than the diameter of the capsule.
- Subjects with a history of intestinal Crohn's disease.
- Women who are pregnant.
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